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Futility
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The hypothesis is that the addition of a transparent cap to the end of the endoscope will increase the detection and diagnostic yield of visible lesions in Barrett's esophagus. Thus, the goal of this tandem design trial is to compare the diagnostic yield (DY) of cap assisted endoscopy with that of conventional endoscopy using high definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI) in patients with Barrett's esophagus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: EGD with cap first, followed by EGD without cap | Experimental | -Participants in the first arm will undergo EGD with cap first, followed by EGD without cap in the same procedural period. |
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| Arm 2: EGD without cap first, followed by EGD with cap | Experimental | -Participants in the second arm will undergo EGD without cap first, followed by EGD with cap in the same procedural period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI) | Procedure | -The second endoscopist will be blinded to the results of the initial exam. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had a Diagnostic Yield Obtained | -Diagnostic yield is defined as Barrett's esophagus lesions that were identified and confirmed histologically as low grade dysplasia, high grade dysplasia, intramucosal cancer, or invasive adenocarcinoma | At the time of procedure (day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap | At the time of procedure (day 1) | |
| Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma | At the time of procedure (day 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir M Kushnir, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: EGD With Cap First, Followed by EGD Without Cap | -Participants in the first arm will undergo EGD with cap first, followed by EGD without cap in the same procedural period. |
| FG001 | Arm 2: EGD Without Cap First, Followed by EGD With Cap |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2021 |
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| Olympus Disposable Distal Attachment Cap | Device | -The second endoscopist will be blinded to the results of the initial exam. |
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| Total Procedure Duration in Seconds | At the time of procedure (day 1) |
| Safety as Measured by Number of Participants With Procedure-related Adverse Events |
| Through 48 hours after EGD |
-Participants in the second arm will undergo EGD without cap first, followed by EGD with cap in the same procedural period. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: EGD With Cap First, Followed by EGD Without Cap | -Participants in the first arm will undergo EGD with cap first, followed by EGD without cap in the same procedural period. |
| BG001 | Arm 2: EGD Without Cap First, Followed by EGD With Cap | -Participants in the second arm will undergo EGD without cap first, followed by EGD with cap in the same procedural period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Had a Diagnostic Yield Obtained | -Diagnostic yield is defined as Barrett's esophagus lesions that were identified and confirmed histologically as low grade dysplasia, high grade dysplasia, intramucosal cancer, or invasive adenocarcinoma | Participants had to have visible lesions to be evaluable for this outcome measure. | Posted | Count of Participants | Participants | At the time of procedure (day 1) |
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| Secondary | Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap | Posted | Count of Participants | Participants | At the time of procedure (day 1) |
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| Secondary | Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma | Out of the 100 enrolled participants, there were 2 participants with missing pathology reports. | Posted | Count of Participants | Participants | At the time of procedure (day 1) |
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| Secondary | Total Procedure Duration in Seconds | Posted | Mean | Standard Deviation | seconds | At the time of procedure (day 1) |
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| Secondary | Safety as Measured by Number of Participants With Procedure-related Adverse Events |
| Posted | Count of Participants | Participants | Through 48 hours after EGD |
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Adverse events were collected from start of EGD until 48 hours after EGD.
Adverse events were collected for the entire procedure as a whole and for 48 hours after the procedure and were not separately collected for each part of the procedure (EGD without CAP versus EGD with CAP).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: EGD With Cap First, Followed by EGD Without Cap | -Participants in the first arm will undergo EGD with cap first, followed by EGD without cap in the same procedural period. | 0 | 50 | 0 | 50 | 0 | 50 |
| EG001 | Arm 2: EGD Without Cap First, Followed by EGD With Cap | -Participants in the second arm will undergo EGD without cap first, followed by EGD with cap in the same procedural period. | 0 | 50 | 0 | 50 | 0 | 50 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vladimir M. Kushnir, M.D. | Washington University School of Medicine | 314-454-5960 | vkushnir@wustl.edu |
| Mar 30, 2022 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D016145 | Endoscopy, Digestive System |
| D062048 | Narrow Band Imaging |
| D003274 | Contraceptive Devices, Female |
| ID | Term |
|---|---|
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D008919 | Investigative Techniques |
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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